search
Back to results

Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis

Primary Purpose

Pancreatectomy

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Indomethacin suppository
Standard Medical Treatment
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: *All patients planned to undergo pancreatectomy. Exclusion Criteria: asthma allergic reactions to NSAIDs CKD internal hemorrhoids anti-platelet medications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A

    Group B

    Arm Description

    Patients will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment

    Standard Medical Treatment

    Outcomes

    Primary Outcome Measures

    Post-pancreatectomy Acute Pancreatitis

    Secondary Outcome Measures

    Pancreatic Fistula
    Peripancreatic abscess
    Length of hospital stay

    Full Information

    First Posted
    February 1, 2023
    Last Updated
    February 1, 2023
    Sponsor
    Shanghai Jiao Tong University School of Medicine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05722548
    Brief Title
    Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis
    Official Title
    Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis-A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.
    Detailed Description
    The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatectomy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Patients will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Standard Medical Treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Indomethacin suppository
    Intervention Description
    100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia
    Intervention Type
    Other
    Intervention Name(s)
    Standard Medical Treatment
    Intervention Description
    Standard Medical Treatment
    Primary Outcome Measure Information:
    Title
    Post-pancreatectomy Acute Pancreatitis
    Time Frame
    2 weeks after pancreatectomy
    Secondary Outcome Measure Information:
    Title
    Pancreatic Fistula
    Time Frame
    30 days after pancreatectomy
    Title
    Peripancreatic abscess
    Time Frame
    30 days after pancreatectomy
    Title
    Length of hospital stay
    Time Frame
    30 days after pancreatectomy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: *All patients planned to undergo pancreatectomy. Exclusion Criteria: asthma allergic reactions to NSAIDs CKD internal hemorrhoids anti-platelet medications
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yingbin Liu, PHD
    Phone
    +8613918803900
    Email
    laoniulyb@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yingbin Liu, PHD
    Organizational Affiliation
    RenJi Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis

    We'll reach out to this number within 24 hrs